modular. scalable. future-proof....dissolution test. the sequence of individual process steps before...

Modular. Scalable. Future-proof.XtendTM Dissolution Line

Manual & Semi-AutomatedUSP 1, 2, 5, 6

Future-proof.

Scalable.

Modular.

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ServicesXtendTM Manual Semi-Automated

The XtendTM Dissolution Line

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The ability to flexibly respond to permanent change in today’s fast-paced pharmaceutical environment can make the difference between success and failure. Fast time-to-market requirements, outsourcing, relocations, shift of manufacturing capacities and short return on investment considerations ask for equally flexible testing solutions in R&D and QC laboratories. The fully scalable and modular XtendTM concept is 100% based on this basic premise and allows you to tailor dissolution testing to both your current and future needs – making your investment future-proof.

Modular. Standardized XtendTM modules such as the dissolution bath, pump, filter station, and sample manager can be flexibly combined for different automation require-ments – from manual to semi- and fully automated dissolution systems. Irrespective of the configuration, all modules and components of the XtendTM Dissolution Line are extremely robust having been designed for the most demanding conditions of a fully automated system running 24 hours per day.

Scalable. The XtendTM Dissolution Line simplifies method transfer – making scale-up from R&D to QC with different throughput requirements and changing workloads easier than ever. From qualification to writing SOP’s: keep in place what is already used, described and validated.

Future-proof. Secure your investment today and flexibly manage tomorrow’s demands. With a proven track record of thousands of systems installed world-wide and more than 40 years of experience in dissolution testing, the XtendTM Dissolution Line is a safe investment. All system modules incorporate the very latest technology for maximum efficiency and provide for highly reliable dissolution testing based on precision-made high quality components.

Ready for tomorrow. Today.

Future-proof.

Scalable.

Modular.

Automating DissolutionDefining the level of automation that best fits the product and throughput requirements can help to ensure reproducibility and standardization of your dissolution test.

The sequence of individual process steps before (pre-run), during (dissolution run), and after (post-run) the dissolution test include:

ManualWhen dissolution is performed manually, every process step before, during, and after the test is executed manually by the user. This is the most analyst-dependent way of testing.

Semi-automatedSemi-automated systems ensure that all sequential steps during the dissolution run are reproducibly executed without requiring user interaction until the postrun activity.

Fully automatedFully automated systems automate the complete dissolution process – from preparation to cleaning. Several tests of the same or different products can be executed directly after each other – without requiring any user action.

Requires user presence and interaction (analyst-dependent)

Does not require user presence and interaction (analyst-independent)

Pre-test Dissolution test Post-test

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ServicesXtendTM Manual Semi-Automated

Immediate Release test (30 mins) based on:• UV-Vis analytical configuration• 1 sampling point• 1 operator

The main drivers for selecting your level of automation are:• Number of tests per day• Duration of test• Number of sampling time points• Analytical method• Number of additional process steps (e.g. pH changes)

Automation and standardization of individual process steps ensure repeatability and allow handling of higher volumes. For high throughput requirements, semi- and fully automated dissolution systems offer a fast return on investment (ROI), shorten test cycle times, reduce operator variability and therefore improve reproducibility.

Experts in Automation

With more than 40 years of experience in automation, SOTAX dissolution systems are proven to be a safe investment. Our manual, semi- and fully-automated solutions are used in R&D and QC departments every day. Compliance by design, reliable technology and competent local service have made SOTAX dissolution systems the preferred choice of leading pharma-ceutical companies all over the world.

Manual process time (per 1 day)

manual semi-automated fully automated

Automation Level

Lots /Time

Productivity (lots completed on 1 day)

Reduction of operator variability & increase of reproducibility

Automating DissolutionDefining the level of automation that best fits the product and throughput requirements can help to ensure reproducibility and standardization of your dissolution test.

The sequence of individual process steps before (pre-run), during (dissolution run), and after (post-run) the dissolution test include:

ManualWhen dissolution is performed manually, every process step before, during, and after the test is executed manually by the user. This is the most analyst-dependent way of testing.

Semi-automatedSemi-automated systems ensure that all sequential steps during the dissolution run are reproducibly executed without requiring user interaction until the postrun activity.

Fully automatedFully automated systems automate the complete dissolution process – from preparation to cleaning. Several tests of the same or different products can be executed directly after each other – without requiring any user action.

Requires user presence and interaction (analyst-dependent)

Does not require user presence and interaction (analyst-independent)

Pre-test Dissolution test Post-test

Asse

mbly

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t-up

Dosa

ge Fo

rm

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trodu

ction

Filter

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Media

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XtendTM Manual ServicesSemi-Automated

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→ AT Dissolution Apparatus

AT Dissolution ApparatusThe AT dissolution bath is the heart of the Xtend™ Dissolution Line. Whether used as a manual apparatus or as the core component in an automated dissolution system – the AT has been designed for the most demanding environments. Built on the success of preceding SOTAX dissolution systems, the AT can be flexibly configured for USP 1,2,5,6 dissolution methods. Its unique design combines robust quality components with state-of-the-art technology to guarantee reproducible testing conditions, day after day. Depending on the required automation level, the AT can be flexibly extended with additional XtendTM modules – making method transfer for increased throughput requirements easier than ever.

→ AT Dissolution Apparatus

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Innovative Circular Design

The AT dissolution bath with 6-8 vessels sets new standards for quick and easy operation. At the same time, it opens up a new dimension of observation possibilities for R&D visualization and OOS troubleshooting.

→ Circular bath design with central video monitoring of each vessel

100% visibility Understanding the release characteristics of formula-tions requires full visibility of samples during the disso-lution test. Depending on your observation needs, the circular AT bath allows visual observation of each vessel from the outside and additionally from the inside using video monitoring. To view the behavior of samples from the bottom, an optional mirrored base plate is available.

CenterViewTM video monitoringThe unique CenterViewTM design provides perfect visual-ization and video recording of release processes in each vessel. For optimum visibility, indirect light is integrated into this space-saving design. An easy-to-attach privacy shield protects the user from being monitored.

Precise temperature controlLike its predecessor model, the AT dissolution bath has been optimized for ideal water circulation to ensure ex-tremely high temperature homogeneity during the test.

Easy handling and cleaningFrom fast filling and draining of the water bath with quick-connector, self-priming circulation pump, to motor-ized lift function all handling and cleaning processes of the AT have been optimized for simple and fast execution. When adding test medium or removing vessels, the verti-cally lifted shaft drive provides excellent accessibility during all change-over and cleaning processes.


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→ Assisted closing mechanism for precise centering and positioning

quick-lock quick-lock

quick-lock

Compliance by Design

The AT dissolution apparatus fully complies with all harmonized Pharmacopeia requirements and features “built-in” compliance without any adjustment.

The proven SOTAX AutoComplianceTM concept with fixed shaft height and vessel positioning guarantees 100% compliance without requiring time-consuming adjustments by the operator. For fast change-overs, quick-lock systems and a vertical bath closing mechanism (manual or motorized) provide for simple handling processes.

→ Auto-centering vessels with quick-lock system → Fixed shaft height with quick-lock system

Auto-centering vesselsTime-consuming vessel set-up is unknown with the AT’s auto-centering quick-lock system. Locking rings, which are fixed on the base plate, guarantee highly accurate vessel centering and allow analysts to insert or remove vessels within seconds. Each vessel is certified and closed with an individual cover limiting evaporation.

Fixed shaft heightProven to have the lowest wobble ratings in the industry, the AT incorporates the same shaft design as previous SOTAX dissolution baths. All shafts are self-centering and no adjustment of shaft height is required – maintain-ing the highest level of precision while making change-overs fast and simple.

Highest repeatabilityDuring dissolution tests, stirring speed and temperature are continuously monitored. To ensure reproducible con-ditions, all shafts and vessels are identified with a unique serial number.

Fully documented qualificationThe AT has been designed to facilitate highly accurate mechanical calibration anytime. Using the innovative Mechanical Qualification Device (MQD), all required pro-cedures and measurements can be easily performed and results are automatically documented according to the current FDA guidelines on enhanced mechanical qualification.

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Flexibility Maximized

Large inlet dimensions allow for a wide variety of tablet and sinker types to be introduced manually or automatically. For full flexibility, the AT can be operated with various stirrer and vessel types.

Suited for all dosage formsFrom standard tablets to capsules with large sinkers – the AT dissolution bath is capable of handling virtually all dosage forms. Samples are protected from media before test start. As the inlets are closed during the test, media evaporation is prevented.

Different vessel styles For full flexibility, the AT bath accommodates a broad variety of different vessel styles – from certified stan-dard glass vessels to polycarbonate or low actinic glass vessels, 1 or 2 liter vessels, mini vessels, China vessels, and peak vessels.

USP 1,2,5,6 and moreDeveloped for USP 1,2,5,6 methods, the AT allows testing with different compliant and also non-compliant stirrer designs. All parts are made of high quality material, are serialized and certified.

1 L vessel

PaddleBasket Rotating cylinder

Rotating cylinder

Paddle over disk

Paddle over disk

Paddle over disk

Extraction cell

Mini paddle

China paddle

Stationary basket

Intrinsic dissolution

2 L vessel Mini vessel

Immersion cell vessel

Peak vessel

China vessel


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User-friendly with EasyTouchTM

Simple and intuitive touch screen operation makes test set-up and method programming easier than ever. Logical, icon-based menu structures reduce analyst training times to a minimum.

The large integrated 6.9" color touch screen sets new standards for efficient operation. User rights settings, method programming and reporting are readily available at the touch of a button. Various communication ports allow local and network printing and full system control by PC software whenever needed.

Method programming is as flexible as never before. Time points can be used independently for any events (sampling, media addition or change, change of stirrer speed, filter change or in-vessel temperature measurement). Additional functions like tube cleaning routines and delayed start possibilities further extend the flexibility.

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The AT dissolution bath can be flexibly combined with additional XtendTM Modules for automated sample collection and storage – including UV-Vis and LC integration.

Analytical Configuration

Off-line Systems• Scalable collection and storage of samples

into standardized tubes or vials• Sample protection from temperature and

light degradation• Use of vertical space to reduce footprint

UV-Vis On-line Systems• Automated UV-Vis measurements for real

time results• Single dissolution software for raw data

acquisition and flexible calculation• Automates the manual sample transfer

which can be a source of manipulation error• Allows unattended dissolution run, results

being stored and saved automatically

UV-Vis On/Off-line Systems• Flexibility: fraction collection and/or UV-Vis

measurements for sample archival or UV-Vis/LC immediate comparison

LC On/Off-line Systems• Automated LC injections for real time results• Automates the manual sample transfer

which can be a source of manipulation error• Allows back-up sampling• Space-saving integrated system• Sample flow controlled by WinSOTAXplus

compatible with any existing LC software

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Workflow ConfigurationFrom media preparation to system cleaning – the XtendTM Dissolution Line allows streamlining the entire workflow to guide method development and simplify routine operation.

Media PreparationAccurate media preparation plays a vital role in all subsequent processes. The MPS Media Preparation Station allows operators to degas, heat, and dispense the exact volume of dissolution media required for each method.

Degassing at the USP and FDA recommended levels, the MPS is a mobile unit assisting in bringing 10 – 20 L of degassed and heated media to your dissolu-tion system. By inserting the dispensing nozzle into individual vessels, precise and gravimetrically validated dispensing of media at 1’500 mL per minute with-out re-aeration is achieved. Once dispensing has been completed, the MPS can be simply connected to the next DI water inlet to start its automated cleaning routine – while the dissolution test runs.

← Gravimetric volume confirmation with balance

→ MPS Media Preparation Station

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← HollowShaftTM Automatic sampling with minimum

hydrodynamic pertubation

→ Automated cannula with AutoLiftTM for maximum flexibility

in sampling and monitoring

Complete Sampling Solutions

Automating the sampling process improves accuracy, reproducibility and simplifies method transfer. Standardized modules for sample withdrawal allow sampling tailored to your application.

For dissolution sample withdrawal, four key factors must be considered: height reproducibility, automation potential, hydrodynamic impact and temperature monitoring. Automating the process with simultaneous sampling and automatic pumping improves time and volume accuracy. Based on your requirements, the XtendTM Dissolution Line offers a variety of manual and automatic sampling possibilities:

• Simple manual sample withdrawal using a glass pipette• Stand-alone type sampling probe with additional pipette guide• Stationary cannula in different materials and diameters for

sampling with disposable syringes• Automatic simultaneous sampling with the unique HollowShaftTM –

reducing hydrodynamic perturbation• Automatic simultaneous sampling with cannula and AutoLiftTM

for maximum flexibility

Glass pipette or sampling probe

Glass pipette or sampling probe with

pipette guide

Stationarycannula

HollowShaftTM Automated cannula

(AutoLiftTM)

Height reproducibility

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Automation potential

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Reduction of hydrodynamic impact

− − − −

Temperaturecoupling

− − − −

← HollowShaftTM Automatic sampling with minimum

hydrodynamic pertubation

→ Automated cannula with AutoLiftTM for maximum flexibility

in sampling and monitoring

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Simultaneous Sample Withdrawal

The accuracy of sample transfer from the dissolution apparatus to the sample manager and/or analytical device largely depends on the accuracy of the pump used and on its ability to push or pull liquids through the filters.

As sample transfer occurs simultaneously on all channels, any pump used must contain 6-8 equiv-alent modules. In addition to traditional peristaltic pumps used in UV-Vis on-line systems, the XtendTM Dissolution Line also offers additional sampling options with the SAM Sample Manager.

Syringe Pump Module Containing 6-8 precision syringes, the module is integrat-ed in the SAM dispensing head for off-line dissolution systems. This simple and space-saving design allows simultaneous transfer of samples through filters with a porosity down to 1 micron into test tubes or LC vials. For seamless integration, the syringe pump module can be controlled directly via the EasyTouchTM user interface.

CP Piston Pump ModuleThe CP Piston Pump Module is the ideal choice for auto-mated systems and it can also be used to perform media addition. To reduce the overall footprint, the CP Module is fully stackable with other XtendTM Modules. The ceramic piston head design is valve-free, requires minimum main-tenance and does not need any priming. Fully controlled by either the EasyTouchTM user interface or WinSOTAXplus Dissolution Software, the powerful CP Module can pull and push through filters down to 0.2 microns. The CP pump allows for high sample collection flexibility from UV-Vis to UPLC finish even when using surfactants.

← Syringe Pump ModuleSimple solution for off-linedissolution systems

→ CP Piston Pump ModuleFlexible and fully stackablesolution for all automated dissolution systems

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Reproducible Filtration at each Time Point

Filtering dissolution samples prior to analysis is essential to the accuracy of dissolution results. The XtendTM Dissolution Line can be operated with different membranes and filters of various porosities.

→ FS Filter Station Automatic exchange of syringe filters for all channels

Membrane filtersThe 25 mm membrane filters can be used with sampling probes, automated cannulas and HollowShaftTM. Integra-tion directly into the suction head makes these filters both economical and user-friendly.

Syringe FiltersThe 25 mm syringe filters offer 100% flexibility as they can be universally used on disposable syringes, sam-pling probes, stationary cannulas, automated cannulas,HollowShaftTM, CP Modules and FS Filter Stations. Ideal for simplified method transfer, they can be used on all automation levels. During method development in R&D, the variety of porosities allow the user to find the filter required for analytical finish. In QC, the robustness and strength of this filter housing guarantees consistency of the filtration surface. Syringe filters are Luer-locked and therefore robust and easy to use.

FS Filter StationTo avoid saturation and clogging of syringe filters, it may be necessary to exchange them after each sampling point. The FS Filter Station automatically exchanges filters and can hold up to 424 filters for filtering through 6, 7, or 8 channels. Robust and fast in operation, the module guarantees liquid-tight circulation at each time point. To reduce overall system footprint, it can be stacked with other XtendTM Modules.

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Universal and Efficient Sample Management

Workload increase or method changes often call for maximum flexibility and scalable sample management – in addition to safe and reproducible collection and storage.

The SAM Sample Manager can be used either as a simple fraction collector to collect and store samples in standardized vials and tubes, or as an advanced sample manager to add or replace media and/or inject samples in an LC or UV-Vis spectrophotometer.

Controlled by the EasyTouchTM user interface or by WinSOTAXplus Dissolution Software, the SAM will fit with all dissolution methods – independent of the automation level chosen. Like all XtendTM Modules, the SAM can be stacked with the CP Piston Pump Module and/or the FS Filter Station to reduce overall system footprint.

Available in four versions (SR/S/M/L), the module allows vertical storage of samples in up to 3 levels. Various types are available to extend the capacity for semi-automated double systems or for an increased number of time points.

1 rack = 120 samples8 channels15 time points

SAM SSAM SR SAM M SAM L

Universal and Efficient Sample Management

Workload increase or method changes often call for maximum flexibility and scalable sample management – in addition to safe and reproducible collection and storage.

The SAM Sample Manager can be used either as a simple fraction collector to collect and store samples in standardized vials and tubes, or as an advanced sample manager to add or replace media and/or inject samples in an LC or UV-Vis spectrophotometer.

Controlled by the EasyTouchTM user interface or by WinSOTAXplus Dissolution Software, the SAM will fit with all dissolution methods – independent of the automation level chosen. Like all XtendTM Modules, the SAM can be stacked with the CP Piston Pump Module and/or the FS Filter Station to reduce overall system footprint.

Available in four versions (SR/S/M/L), the module allows vertical storage of samples in up to 3 levels. Various types are available to extend the capacity for semi-automated double systems or for an increased number of time points.

1 rack = 120 samples8 channels15 time points

SAM SSAM SR SAM M SAM L

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UV-Vis AnalysisThe WinSOTAXplus Dissolution Software is 21 CFR, Part 11 compliant and full control of a variety of UV-Vis spectrophotometers. Dissolution samples can be with-drawn, filtered and measured in “Absorbance” at single- or multi-wavelength in flow-through cuvettes. The read-ings are calculated, reported and stored in an SQL database.

Seamless integration with Specord Plus® SOTAX also offers its own UV-Vis solution: the Specord Plus 200 or Specord Plus 210 UV-Vis spectrophotome-ters are fully integrated in the XtendTM Dissolution Line. Both systems exceed Pharmacopeia requirements and have a true double beam with reference compensation. Using two symmetrical 8-position cell changers, they are ideal for double on-line and double on-/off-line system configurations. As a standard, the Specord Plus series comes with a 10 year warranty on optics.

Sample Analysis and Reporting

UV-Vis or LC analysis being the final step of the dissolution process, the XtendTM Dissolution Line allows integration of different analytical processes and combines results in a powerful data management software.

LC

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LC AnalysisLC on-line systems automate manual sample transfer for unattended operation – thus maximizing your LC throughput, increasing efficiency and reducing human errors. The XtendTM Dissolution Line offers two different solutions to seamlessly connect to your existing LC system:

MF MultiFunction Interface for Real Time Sample Transfer Compatible with all LC’s capable of contact closure func-tionality, the MF MultiFunction Interface transfers your dissolution samples as soon as they are withdrawn from the vessel. Handling up to 8 standards, the MF is a robust and simple solution adapted to fast LC analysis.

SAM Sample Manager for Scheduled Sample TransferCompatible with all LC’s capable of contact closure func-tionality, the SAM LC on-line system stores and protects samples in standardized tubes or vials as soon as they are withdrawn. The SAM adds and replaces media if nec-essary and injects samples into the LC. The LC injection workflow is processed in parallel to the dissolution sam-pling with an independent injection syringe. Existing in three capacities, stackable with other XtendTM Modules to save bench space and handling standards from ports or vials, the SAM is the most flexible dissolution sample manager on the market.

Professional Data ManagementDeveloped in close cooperation with industry experts and system users, the WinSOTAXplus software is based on a deep understanding of today’s dissolution user requirements and allows implementation of a fully 21 CFR, Part 11 compliant data management system for all XtendTM configurations and automation levels.

The WinSOTAXplus software offers user-friendly control of your complete system. Whether used stand-alone or in a networked environment, the modern client-server architecture can be flexibly implemented for different needs. From data capture to analysis with customized reporting and exporting features including a complete audit trail – the software fulfills all R&D and QC require-ments. For advanced data management, specific user-group definition and bi-directional data transfer to ELN/LIMS are available.

Simple batch analysis alongside assisted data review is possible with customized reports and method creation including product specifications. Spend less time on compliance paperwork with highlighted pass/fail reports alongside enhanced temperature, rpm, and pH recording throughout the test. Comprehensive standard monitoring and customized system suitability requirements are stored and executed per product to ensure proper SOP execution.

→ WinSOTAXplus Advanced Dissolution Software

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Technical Services

Global. Reliable. Customer-focused. The SOTAX Global Service Network is available worldwide, whenever and wherever you need us.

• System installation and qualification• User training• Preventive maintenance• Technical support (first line responder training)• Repairs• Updates, upgrades, and customization• Compliance services (cGMP compliant qualification:

IQ, OQ, PQ, MQ, PVT, and customer-specific qualification)• Service contracts• Relocations

Associated Services

Application Services

Feasibility study Secure your instrument investment with data confirmation of automation capability on your products

Method development Save time and resources by allowing SOTAX application scientists todevelop your methods in accordance with your method developmentrequirements

Method transfer Use our trained hands to provide method training and facilitate the transfer of your dissolution methods across sites

Method validation Speed rollout by allowing us to facilitate and document validation of your method on-site

Application support at installation

Screen your applications for ROI and develop an efficient planfor integrating automation into your laboratory

Application training Come to our labs or invite SOTAX into yours to work with our application experts to streamline the dissolution workflow

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Sole Partner in China

+852 2569 2154HKFind out more +86 21 6351 1828SH

+86 20 8329 2451GZ

BJ +86 10 6527 8522 [email protected]

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modular. scalable. future-proof....dissolution test. the sequence of individual process steps before...

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